drugset / Trial / NCT01425164

Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

NCT01425164

RandomizedParallel-groupTriple-blindTreatment

Summary

In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.

Timeline

Start
2011-01
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carvedilol Other / unclassified 12.5 mg
Comparator Carvedilol Other / unclassified 25 mg
Subject Ivabradine Small molecule 5 mg
Subject Ivabradine Small molecule 7.5 mg